Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
FDA Recall Z-0364-2016 · Posted None
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2014-08-19
Date Terminated2016-06-14
Product Quantity1517 systems, not all units have the patient support accessory
Reason for Recall
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Firm Action
The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.
Root Cause
Device Design
Distribution Pattern
Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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